R-3750 in Patients With Crohn's Disease
ConditionCrohn Disease (CD)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRise Therapeutics LLC
About this trial
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, clinical activity, and pharmacodynamic effects of R-3750 in adults with active Crohn's disease. Approximately 40 participants will be randomized 1:1 to receive R-3750 or matching placebo orally once daily for 12 weeks. Participants will be followed for safety, clinical response, and durability of response through approximately Day 168. Assessments will include adverse events, Crohn's disease activity, endoscopic response, patient-reported outcomes, inflammatory biomarkers, microbiome composition, and pharmacodynamic measures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 80 years, inclusive, at the time of informed consent.
Able and willing to provide written informed consent and comply with study procedures and study visits.
Documented diagnosis of Crohn's disease with symptoms/onset of disease at least 3 months prior to Screening.
Active Crohn's disease defined by Harvey-Bradshaw Index (HBI) score between 5 and 15 at Screening.
Disqualifiers
Crohn's disease in clinical remission, including HBI <5 or CDAI <150 at Screening.
Severe Crohn's disease requiring urgent escalation of therapy, hospitalization, or surgery in the opinion of the Investigator.
Imminent risk of scheduled intestinal surgery, including clinically significant stenosis, strictures, internal fistula, abscess, or obstructive complications.
History of partial or incomplete bowel obstruction within 6 months prior to Screening; current stoma, ileostomy, colostomy, or anticipated need for ostomy during the study; diagnosis of short bowel syndrome or clinically significant malabsorptive condition; uncontrolled chronic diarrhea due to a condition other than Crohn's disease; or bowel resection within 3 months prior to Screening.
Trial design
Design model
Parallel
Treatments tested in this trial
R-3750
DrugR-3750 DP is a live biotherapeutic product consisting of Lactococcus lactis engineered to express Surface Layer Protein A (SlpA), formulated in enteric-coated capsules for oral administration. Participants randomized to R-3750 will receive 9E10 colony-forming units (CFU) per day orally once daily from Day 1 through Day 84.
Placebo
DrugMatching placebo will be administered orally once daily from Day 1 through Day 84.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Arm 1: R-3750, 9E10 CFU/day orally once daily for 12 weeksExperimental treatment 1 intervention
Group B: Arm 2: Matching placebo orally once daily for 12 weeksPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Adverse Events.
Number of participants experiencing one or more treatment-emergent adverse events following administration of R-3750 or placebo.
Time frame
From first dose through Day 168 end of studySecondary outcomes
1
Number of participants with serious adverse advents
Number of particpants experiencing one or more serious adverse events following administration of R-3750 or placebo.
Time frame
From first dose through Day 168 end of studyOther outcomes
1
Number of Participants with Clinically Significant Abnormal Clinical Laboratory Results
Number of participants with clinically significant abnormalities in protocol-specified hematology and clinical chemistry laboratory assessments.
Time frame
From baseline through Day 168 end of study2
Number of Participants with Clinically Significant Abnormal Vital Signs
Number of participants with clinically significant abnormalities in protocol-specified vital sign assessments.
Time frame
From baseline through Day 168 end of study3
Number of Participants with Clinically Significant Abnormal Physical Examination Findings
Number of participants with new or worsened clinically significant physical examination findings after baseline.
Time frame
From baseline through Day 168 end of studyLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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